WC45725: RO7795068 in Participants with Obesity or Overweight (Enith 1)
Research type
Research Study
Full title
A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ONCE-WEEKLY RO7795068 ADMINISTERED TO PARTICIPANTS WITH OBESITY OR OVERWEIGHT WITHOUT TYPE 2 DIABETES
IRAS ID
1013377
Contact name
N/A N/A
Contact email
Sponsor organisation
F. Hoffmann-La Roche AG
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
This Phase III study is addressing the global health challenge of chronic weight management. Obesity is a condition where a person has too much body fat, which can harm their health. It is often measured using the Body Mass Index (BMI), where a BMI of 30 or higher indicates obesity. Obesity can lead to serious health problems like diabetes and heart disease. Managing obesity usually involves a combination of eating fewer calories, exercising more, and sometimes taking medications or having surgery. The goal is not just to lose weight but to improve overall health and well-being.
This study is testing a drug called RO7795068. It is being developed to treat obesity and overweight in adults without Type 2 Diabetes Mellitus (T2DM). This study aims to compare the effects of RO7795068 against a placebo in people with obesity or overweight without type 2 diabetes.
This is a Phase III, randomised, double-blind, placebo-controlled study, ensuring participants and investigators do not know who is receiving the active drug to minimise bias.
People 18 years and older with obesity or overweight can take part in the study if they have at least one weight-related health issue. They must be willing to follow the study procedures, be able to give themselves the study drug or have someone help them, and have tried unsuccessfully to lose weight through diet and exercise before.
The study will last approximately 79 weeks for each participant (which is about 1.5 years). This includes a screening period, a 72-week treatment period, and a safety follow-up period.
There will be approximately 103 patients recruited at 10 UK sites and 2000 worldwide.
The study is sponsored by F. Hoffmann- La Roche
Lay summary based on the WC45725 Protocol, Version 1, dated 24 September 2025.REC name
Wales REC 5
REC reference
26/WA/0054
Date of REC Opinion
11 May 2026
REC opinion
Further Information Favourable Opinion